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NCT04607304

ABCA2 GIRMS Analytical Validation Clinical Performance Study

ABCA2 GIRMS Analytical Validation Clinical Performance Study - Patient Sample Collection
Cairn Diagnostics·ClinicalTrials.gov·device·Device trialCompleted
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Study focus
Disease/Condition
Gastroparesis
Drug/Device/Intervention
ABCA2 GIRMS
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Cairn Diagnostics
Location
Brentwood, United States of America
Timeline & enrollment
Phase
N/A
Start date
Oct 08, 2020
End date
Jul 27, 2021
Enrollment
95 participants
Primary outcome

Diagnostic agreement at each individual timepoints,Percent agreement in diagnosis

Summary

The purpose of this study is to collect human breath samples for use in a validation study
 intended to demonstrate equivalent clinical performance measures of new ABCA2 GIRMS
 (Automated Breath Carbon Analyzer-2 Gas Isotope Ratio Mass Spectrometer) instruments to the
 currently FDA-approved ABCA GIRMS (Automated Breath Carbon Analyzer Gas Isotope Ratio Mass
 Spectrometer) system. ABCA GIRMS systems are used to analyze the ratio of 13CO2 to 12CO2 in
 patient breath samples during the GEBT (Gastric Emptying Breath Test) procedure.

ICD-10 classifications
Attention to gastrostomyGastrostomy statusOther gastritisGastritis, unspecifiedGastric diverticulum
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04607304
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT04607304 through Pure Global AI's free database. This phase not specified trial is sponsored by Cairn Diagnostics and is currently Completed. The study focuses on Gastroparesis. Target enrollment is 95 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.